GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

The Effect of Exenatide Compared to Lantus Insulin on Vascular Function in Type 2 Diabetes

The Effect of Exenatide Compared to Lantus Insulin on Vascular Function Before and After a Meal Tolerance Test in Patients With Type 2 Diabetes

Lead sponsor

Joslin Diabetes Center

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Primary Endpoint Was the Change in FMD at the End of the Study Compared

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00353834

Org study IDCHS #05-45

Timeline

Milestones

Study first posted2006-07-19estimated

Last update posted2018-01-09actual

Results first posted2018-01-09actual

Study start2006-08 (month precision)

Primary completion2010-09actual (month precision)

Study completion2010-09actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•age 18-75

•Type 2 Diabetes (diagnosed at least 3 months prior to study)

•HbA1c: above 7.0 and less than or equal to 10.0

•At least one HbA1c over preceding 3-6 months, and HbA1c at screening, with less than 1% difference between lowest and highest values

•Stable doses of antidiabetic medications (SU and/or Metformin) for 3 months

•reproductive age females must have negative urine HCG at screening, and be using appropriate contraception during the study or be surgically sterile

•postmenopausal woman

•stable weight for 3 months prior to study (+/- 2kg)

•willingness to participate in the study

Exclusion criteria

•Type 1 diabetes

•Type 2 diabetes less than 3 months in duration

•HbA1c less than 7.0 or greater than 10

•age less than 18 or greater than 75

•pregnant or planning to become pregnant during study period

•current insulin therapy or insulin within 6 months prior to study

•current use of Thiazolidinedione or within 6 months prior to study

•current use of Nateglinide or Repaglinide

•current use of an Alpha-glucosidase Inhibitor

•current weight loss program

•active smoker, or quit smoking within preceding 6 months

•creatinine greater than 2.0 mg/dL

•total cholesterol greater than 300 mg/dL

•triglycerides greater than 600 mg/dL

•blood pressure greater than 160/105 mmHg

•ALT/AST greater than twice the upper limit of normal

•any other medical condition that may interfere with trial participation or trial results

•if on Statin: Statin therapy for less than 3 months or dose change within preceding 3 months

•if on ACE Inhibitor: ACE Inhibitor therapy for less than 3 months or dose change within preceding 3 months

•current use of any medication that is known to alter gastric motility

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint/low confidence

Fourth Will be Changes in Insulin, Glucose, C-peptide, Lipids, and FFA Responses Following the MTT in Subjects Treated With Exenatide Compared With Subjects Treated With Lantus at the End of the Study Compared to Baseline Measurement

Time frame:Baseline and end of study